Submitted by kBLASTER Team on
January 15, 2015 by Mark Hollmer for MassDevice
Intact Medical said it nailed down expanded 510(k) clearance from the FDA for its eponymous breast biopsy system for preserving larger lesion samples up to 30 mm in diameter.
President & CEO John Vacha of Intact Medical said the expanded FDA clearance could help make the Intact system a go-to device rather than an alternative option.
"The impact of this new, expanded application of the Intact technology means that Intact could be a welcomed 1st-line alternative diagnostic procedure to open surgical excision, significantly reducing patient discomfort, recovery time and costs," Vacha said in prepared remarks.
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